Compliance is one of the key words in a pharmaceutical (production) environment: “Just say what you do and do what you say.” It sounds very simple, but time constraints, undercapacity or conflicting priorities often make it difficult to put into practice. Nevertheless, organisations must attend to these matters. During (government) inspections, organisations are assessed to see whether they comply with agreements and regulations. When organisations neglect their compliance and quality responsibilities because they have simply been too busy with their everyday business, the inspectors may assess them as GMP-unsatisfactory (Good Manufacturing Practice).
How can Progress-PME help you with this?
For many companies, initiating an improvement programme will be the result of an IGZ (Health Care Inspectorate) or FDA (Federal Drug Administration) inspection. We have extensive experience with guiding organisations through these inspections. Staff at Progress-PME can help formulate a response to the inspection findings and support the development and implementation of an improvement programme. In order to identify the problems, we will often start by performing a GAP analysis. This allows us to compare the existing situation with what is desired. In close consultation with your organisation, based on Quality Risk Management (QRM), we can define improvement actions.
It is vitally important that your organisation is closely involved in each change from the start. Eventually the organisation will have to be able to operate independently in compliance with these new agreements. Our approach will lead to successful implementation and the use of practicable procedures related to training and qualification of staff, self-inspection, PQR (Periodic Quality Review), change control, OOS (out of specification) deviations and CAPA (Corrective And Preventive Action).
Front office/back office
We can also organise the entire inspection in a structure according to front office/back office, with a clear and effective role allocation of host, scribe (minutes secretary), runners and subject matter experts. The employees involved will be trained in the do’s and don’ts during an inspection and we hold mock inspections in preparation. This method has proved its worth many times in practice. Both customers and the inspecting bodies have found this method to be effective and enjoyable.